Safety questions about new vaccine may prompt suits

Recent reports of adverse reactions to a new vaccine for young women, including eleven deaths, may lead to suits against Merck, the vaccine’s manufacturer.

A number of states have mandated the vaccine, Gardasil, for school-aged girls.

Gardasil is designed to protect women aged 9 to 26 against the human papillomavirus (HPV), which can cause cervical cancer.

Several law firms across the country are already advertising that they are available to take Gardasil cases.

However, the vaccine was recently added to the National Vaccine Injury Compensation Program list, and therefore any claims against Merck must first go through that fund.

The vaccine, which is administered in three shots, has been controversial, with some urging it be made mandatory and others protesting that it will encourage teenage sex.

Meanwhile, Merck has launched a national marketing campaign, including television ads using a “One Less” theme to suggest the vaccine will reduce the number of cervical cancer cases one by one.

According to the National Conference of State Legislatures, at least 17 states have enacted legislation to require, fund or educate the public about the HPV vaccine, and in 2007 at least 24 states and the District of Columbia introduced legislation specifically mandating the HPV vaccine be required for students. (California and Maryland later withdrew their bills).

New reports

New documents obtained from the FDA detail over 3,000 reports of adverse reactions since Gardasil was approved, ranging from minor side effects such as nausea and dizziness to more serious problems like seizures, spontaneous abortion, paralysis and death.

The reactions were reported by physicians, patients or parents to the Vaccine Adverse Event Reporting System (VAERS), which is maintained by the FDA and the Centers for Disease Control.

Of the eleven deaths reported, one involved a 17-year-old girl who was found unconscious in June 2007 several hours after receiving the first dose. Another involved a 12-year old with a history of heart problems who died in March 2007 on the same day as her first dose, after experiencing a quickening heart rate.

A third case reported by a physician in August 2007 involved an “otherwise healthy” 13-year-old who experienced “paralysis from the chest down [and] lesions of the optic nerve,” after two doses of the vaccine.

The documents were obtained under two Freedom of Information Act requests by Judicial Watch, a watchdog group in Washington.

The organization is still in litigation with the FDA to uncover any communications between the FDA and Merck or third parties as well as correspondence regarding any new drugs relating to the HPV virus.

“Our main interest in the HPV vaccine was triggered by the rush to mandate it. Immediately after approval, it was put on the vaccine schedule and there has been a very strong push on the state and local level to vaccinate girls as young as 9 years old,” said Dee Grothe, program manager at Judicial Watch.

She added that the side effects advertised by Merck include only typical reactions, such as flu-like symptoms, fainting, nausea and dizziness, and not the more serious ones reported to VAERS.

Merck was unavailable for comment on this article.

Grothe noted that Judicial Watch is also seeking documents from the FDA regarding a similar vaccine manufactured by GlaxoSmithKline.

That vaccine, Cervarix, is currently marketed in Europe but has not yet been approved for use in the U.S., Grothe said.

Injury claims

Sean Cronin, an attorney in Jacksonville, Fla., is representing a 12-year-old girl, Brittany Bell, who collapsed after receiving the vaccine in September 2007 and suffers paralysis in her legs.

Cronin said he has not yet filed a claim under the National Vaccine Injury Compensation Program but is researching whether it is the exclusive remedy.

Kevin Conway, an attorney in Boston who has handled vaccine claims for 20 years, including one of the test cases over whether mercury in vaccines causes autism, is currently representing a young woman who experienced seizures immediately after receiving Gardasil, but he said the case is in the embryonic stage.

The compensation fund, which was created in 1988 to protect drug companies against lawsuits and encourage new vaccines, is the first resort for injuries caused by a vaccine, Conway said.

Damages are capped at $250,000 for pain and suffering and an additional $250,000 for death benefits. Attorney fees are paid, but sometimes only after substantial work has been performed, he added.

A claimant who loses a claim before the fund or decides to reject an award from the fund can sue in court, but this almost never happens. That is because the fund is a no-fault system, but a plaintiff in a civil suit is subject to a higher burden of proof, and must face such obstacles as a Daubert hearing to evaluate the scientific evidence and meeting a negligence standard.

“There’s very little case law in this area as there have been only a few civil lawsuits,” Conway said. “However, in my view, a plaintiff would need to show the manufacturer did something seriously wrong.”

In the autism cases, he said, the toxic effects of mercury are so well-established that if manufacturers knew it existed in vaccines, fault could be easily established, he said.

“Much less is known about Gardasil. But certainly, if Merck withheld information from the FDA, it would be liable,” Conway suggested.

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writer at: sylvia.hsieh@lawyersusaonline.com